FDA Proposes to Extend Tobacco Authority to Include E-cigarettes, Other Unregulated Products

AAFP to Closely Scrutinize, Comment on Proposal

On April 24, the FDA proposed a new rule(s3.amazonaws.com) that would extend its authority to regulate tobacco products. Specifically, the agency would "deem" currently unregulated products, including electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables, as meeting the statutory definition of "tobacco product," therefore rendering them subject to FDA regulatory authority under the Family Smoking Prevention and Tobacco Control Act.

In an April 24 conference call about the new rule, Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products, said, "Products that didn't exist a decade ago are now being used by youth and young adults alike. Between 2000 and 2011, use of non-cigarette combustible products increased 123 percent. Between 2011 and 2012, e-cigarette use doubled in popularity amongst middle-school and high-school-age students. A deeming final rule will help FDA keep pace with this rapidly evolving landscape."

The proposed rule would extend the FDA's authority under the Family Smoking Prevention and Tobacco Control Act that President Obama signed in 2009, which allowed the agency to regulate the manufacture, distribution, and marketing of cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

Story highlights

The FDA has proposed a new rule that would extend its authority to regulate tobacco products, including electronic cigarettes (e-cigarettes), cigars, pipe tobacco and other currently unregulated products.

Some elements were not addressed in the proposed rule, including regulating flavoring of e-cigarettes and cigars, marketing to kids, and self-service displays.

The proposed rule will be available for public comment for 75 days.

Manufacturers of products deemed to be tobacco products in accordance with the proposed rule would be required to:

register products with the FDA and report ingredients,

market new tobacco products only after FDA review,

make no direct or implied claims of reduced risk unless the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health, and

not distribute free samples.

Minimum age and identification restrictions would also be required to prevent sales to underage youth, and no vending machine sales would be permitted, unless the machines are located in facilities that do not admit youth.

Proposed Rule Doesn't Cover Everything

Even though the proposed rule is a significant move toward further limiting tobacco use in the United States, according to some stakeholders, there are regulatory elements it does not address.

Sen. Richard Durbin, D-Ill., who has repeatedly called for federal regulation of e-cigarettes, contends that the FDA's proposed restrictions on those and other currently unregulated tobacco products do not do enough to protect kids.

"Faced with a responsibility to protect our children from an addiction to a product that can harm them, the FDA strained to create a political compromise," Durbin said in an April 24 statement(www.durbin.senate.gov).

"Prohibiting sales to kids -- but doing nothing to protect children from candy-flavored marketing in children's venues -- is an awful outcome."

Zeller addressed the issue of regulating tobacco flavoring during the conference call, saying, "We are very aware of the concerns about the presence of flavors that may be particularly attractive to kids. You will see in the preamble (of the proposed rule), all of the questions that we pose about flavors, that we are looking for more information in response to, and to better understand flavors in both currently regulated products and unregulated products."

Gerie Voss, of the FDA tobacco center's office of regulations also spoke during the call, noting that, "FDA is also not proposing to categorically ban flavors of newly deemed products. In order to do this, FDA must issue, through the rulemaking process, a tobacco product standard under section 907 of the Food, Drug, and Cosmetic Act.

"FDA is currently assessing available research regarding the impact of flavors on tobacco product use and is funding research on this issue."

Regarding the regulation of marketing deemed tobacco products to youth, Voss said, "Once a tobacco product is deemed, the law's general prohibition on false and misleading promotion will apply, as well as the prohibition on unauthorized use of modified risk claims.

"In addition, FDA may put in place restrictions on the sale and distribution of those products, including further specific advertising and promotion restrictions. These restrictions will require separate rulemaking and comment."

During the Q&A portion of the FDA call, Dennis Henigan, director of policy analysis and research for the Campaign for Tobacco-Free Kids, asked why restrictions are proposed on vending machines but not on self-service displays of deemed tobacco products. This would continue to allow cigars and e-cigarette displays to be placed anywhere in the store, including next to the candy aisle, he said.

Noting that confusion around this issue continues, Zeller responded by saying, "The rationale originally for this is that (purchasing products from) these displays still ultimately requires face-to-face interaction … The retailer is responsible for complying with the minimum age restrictions by checking photo ID for anyone they think is under the age of 27."